Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial.

PURPOSE: The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer. METHODS: A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed. RESULTS: The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events. CONCLUSION: The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

Patients' Perceived Valorization Toward Ringing the Cancer Bell at the End of Their Radiation Therapy.

PURPOSE: In recent times, "ringing the bell" at the end of cancer treatment has attracted the attention of health care providers with regard to how this experience impacts patients' mental and emotional health. In this context, a study was conducted at a radiation oncology center in Santiago, Chile, to assess the perceived valorization of patients toward "ringing the bell" at the end of their treatment. It was further determined whether this experience had a positive or negative impact on their mental health. METHODS AND MATERIALS: Two hundred thirty-six patients were invited to respond to a printed anonymous survey that used a Likert scale to evaluate their perceived valorization of "ringing the bell" after radiation therapy. In this survey, patients were also asked questions regarding their background to examine possible trends related to different lifestyles and socioeconomic status. RESULTS: The results showed that 93.6% of participants classified the experience as "positive" or "very positive." There were 6 "negative" responses out of 708 (0.8%) to the 3 questions regarding perceived valorization of the experience and no "very negative" responses. CONCLUSIONS: "Ringing the bell" at the end of radiation therapy can be considered a psychological comfort that positively impacts patients' mental health. No trends related to socioeconomic status were observed.

Clinical relevance of the use of Dentoxol® for oral mucositis induced by radiotherapy: A phase II clinical trial.

BACKGROUND: Severe oral mucositis associated with cancer therapy is a frequent complication that may affect a patient's systemic condition, resulting in interruption and/or prolongation of cancer therapy. Dentoxol® is a medical solution in the form of a mouthwash that has been shown to result in statistically significant improvement in the prevention of severe oral mucositis. However, knowing the measures of the clinical significance of this therapy is important for accurate decision-making. AIM: To describe the clinical impact of Dentoxol® use in severe oral mucositis. METHODS: Clinical significance was measured using the results obtained in a randomized controlled clinical trial previously conducted by the same group of researchers. The measures of clinical significance evaluated were the absolute risk or incidence, relative risk, absolute risk reduction, relative risk reduction, number needed to treat, and odds ratio. RESULTS: The data obtained show that the impact of Dentoxol® on reducing the severity of oral mucositis has important clinical relevance. CONCLUSION: The results of this study justify the incorporation of Dentoxol® mouth rinse into clinical protocols as a complement to cancer therapy to prevent and/or treat oral mucositis secondary to radiotherapy.

Radiation Therapy in Resectable Intrathoracic Sarcomas. A Rare Cancer Network Study.

PURPOSE: Intrathoracic sarcomas (ITS) are considered rare tumors and have a dismal prognosis. We investigated outcomes and risk factors for local control (LC), disease-free survival (DFS), and overall survival (OS) in patients with resected nonmetastatic ITS treated with or without adjuvant radiation therapy (RT) and/or chemotherapy. METHODS AND MATERIALS: Patients from the Rare Cancer Network database were studied. A Kaplan-Meier estimate was used to assess survival curves, and Cox proportional hazards regression was used to assess risk factors for LC, DFS, and OS. RESULTS: Between 2000 and 2017, 121 patients met inclusion criteria. The primary site was lung in 30%, mediastinum in 34%, and pleura in 36%. Thirty-nine percent and 32% received RT and chemotherapy. Median follow-up was 34 months (range, 2-141). LC, DFS, and OS at 10 years were 52%, 18.7%, and 7.2%, respectively. In multivariate analysis, RT (P = .003) and R1 margin status (P = .041) retained a significant association with LC. Only R1 resection (P = .002) remained associated with an increased risk of death in multivariate analysis. Overall, 7 patients (6%) developed grade 3 treatment-related chronic toxicity events. CONCLUSIONS: This joint analysis revealed that OS remains modest in this group of patients, mainly given by the high risk of local and distant failure. Our results suggest that resected ITS can benefit from adjuvant RT.

Why a D2 gastrectomy plus adjuvant chemotherapy is insufficient in locally advanced gastric cancer.

This review discusses all the important published evidence regarding adjuvant treatments in locally advanced gastric cancer. In this process it revealed facts that demonstrate the superiority of radiotherapy and concomitant chemotherapy to chemotherapy alone. Some outstanding work that has not yet been published is also discussed.